Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Airways Disease
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT02231424
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 713
Inclusion Criteria
- Patients of either sex, including children over 6 years
- Chronic obstructive respiratory tract disease. Every doctor was asked to include in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI)
Exclusion Criteria
- Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall severity of the clinical picture rated on a 4-point scale after 3 and 6 weeks
- Secondary Outcome Measures
Name Time Method Assessment of tolerability on a 4-point scale after 3 and 6 weeks Changes in concomitant medication up to 6 weeks Number of awakenings due to night-time dyspnea rated on a 4-point scale after 3 and 6 weeks Assessment of morning coughing with expectoration rated on a 4-point scale after 3 and 6 weeks Assessment of efficacy on a 4-point scale after 3 and 6 weeks Number of dyspnea episodes rated on a 4-point scale after 3 and 6 weeks Changes in dyspnea and/or asthma attacks rated on a 4-point scale after 3 and 6 weeks Number of patients with adverse drug reactions up to 6 weeks Changes in pathological auscultation findings rated on a 3-point scale after 3 and 6 weeks